510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K850338Substantially Equivalent

Emergency Room Pack

Marwood Medical, Inc., Greensboro NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850338 is the FDA 510(k) clearance record for EMERGENCY ROOM PACK, cleared for Marwood Medical, Inc. on . FDA records list 7 510(k) clearances for Marwood Medical, Inc., from to . As of , FDA records show no recalls naming K850338.

Clearance record

Decision date
Received
(56 days to decision)
Review panel
Unknown
Applicant
Marwood Medical, Inc. Box 8712, Greensboro NC
Third party review
No